BEUDAMED
    23 results · 19ms · Sources: EU EUDAMED, US FDA

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    CCPOINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450655504·

    WATERLASE MILLENNIUM

    FDA 510(k)
    FDA Class 2 ·Dental

    SEROJET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 25, 2020

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 4, 2020

    AVALUS AORTIC TISSUE VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 24, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·September 16, 2014

    UNKNOWN ZIMMER RASPS

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code HTR·April 19, 2011

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024